Company: Dade Behring Marburg GMBH Marburg
Date of Enforcement Report: 9/5/01
Class: III
RECALL NUMBER, PRODUCT AND CODE:
Z-0906-1 Behring Coagulation System (BCS) software version 2.2.
REASON:
Leak of piston pump valve introduces air bubbles.
CODES:
Model OVIO03 Version 2.2
MANUFACTURER/RECALLING FIRM:
Dade Behring Marburg GMBH Marburg
RECALLED BY:
Dade Behring, INC., Newark, DE., by letter on January 3, 2001.
FIRM INITIATED RECALL:
Complete.
DISTRIBUTION:
NY, IL and MI.
QUANTITY:
3 units.